Hemodynamic Effects of Two Modalities of Alveolar Recruitment Maneuvers - ICU Patients

NCT05365854 | Unknown

• 1 other identifier: RBPH 2021 GODET 3 (Charm ICU)
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study was to investigate the hemodynamic effects of two alveolar recruitment maneuver strategies in critical care patients with acute respiratory distress syndrome.

Conditions

Cardiac Output; Hemodynamic Optimization; Monitoring Blood Pressure; Stroke Volume; Mechanical Ventilation; Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure is the change in cardiac output during the last 10 seconds of each ARM modality from its baseline value (determined after hemodynamic optimization and before the procedure was performed)

  Cardiac output (l/min) will be measured by invasive monitoring during the last 10 seconds of each recruitment maneuver

  During procedure (last 10 seconds of each ARM modality)

Secondary Outcomes (16)

• The secondary outcome measures are the evaluation of standard hemodynamic monitoring data

  During procedure (last 10 seconds of each ARM modality)

• Standard hemodynamic monitoring data

  During procedure (last 10 seconds of each ARM modality)

• Invasive hemodynamic monitoring data

  During procedure (last 10 seconds of each ARM modality)

• Invasive hemodynamic monitoring data

  During procedure (last 10 seconds of each ARM modality)

• Standard ventilatory monitoring data

  During procedure (last 10 seconds of each ARM modality)

Study Arms (2)

Continuous positive airway pressure (CPAP) then extended sigh

ACTIVE COMPARATOR

Patients assigned to this group will receive a CPAP ARM (40cmH2O during 50 seconds), followed by a 10-minute pause corresponding to a period of return to basal state. Then an ARM by extended sigh (e-sigh) also 50 seconds (driving pressure at 10cmH2O and successive PEEP levels at 10, 15, 20, 25 and 30cmH2O, with respiratory frequency fixed at 30/min in controlled pressure). Hemodynamic (blood pressure, cardiac output, stroke volume) and ventilatory measurements will be performed the last 10 seconds of each recruitment maneuver.

Procedure: Alveolar Recruitment Maneuver (ARM)

extended sigh then continuous positive airway pressure (CPAP)

ACTIVE COMPARATOR

Patients assigned to this group will receive an ARM by extended sigh (e-sigh) during 50 seconds (driving pressure at 10cmH2O and successive PEEP levels at 10, 15, 20, 25 and 30cmH2O, with respiratory frequency fixed at 30/min in controlled pressure), followed by a 10-minute pause corresponding to a period of return to basal state. Then they receive a CPAP ARM (40cmH2O during 50 seconds). Hemodynamic (blood pressure, cardiac output, stroke volume) and ventilatory measurements will be performed the last 10 seconds of each recruitment maneuver.

Procedure: Alveolar Recruitment Maneuver (ARM)

Interventions

Alveolar Recruitment Maneuver (ARM) PROCEDURE

When patient is under general anesthesia, an arterial catheter is placed for cardiac output and stroke volume (SV) monitoring. To avoid pre-load dependency bias, the blood volume will be optimized. A 250mL fluid-challenge of a balanced crystalloid solution is administered under cover of the SV monitoring. If SV variation is greater than 10%, a new fluid-challenge is performed to obtain a reference SV, corresponding to the patient's optimal blood volume.The patient is then "pre-load independent". Then, patients will be randomized into two groups: a first group will receive a CPAP ARM: 40 cmH2O for 50 seconds, followed by a 10-minute break corresponding to a period of return to basal state; then an extended sigh ARM (e-sigh) also lasting 50seconds (driving pressure: 10cmH2O and successive PEEP levels at 10,15,20,25 and 30cmH2O, a respiratory rate set at 30/min in controlled pressure - 5cycles at each PEEP level); a second group will receive the same two ARM modalities in reverse order.

Continuous positive airway pressure (CPAP) then extended sigh; extended sigh then continuous positive airway pressure (CPAP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient over 18 years old
• Patient under general anesthesia
• Intubated patient under controlled invasive mechanical ventilation
• Patient with invasive hemodynamic monitoring allowing monitoring of cardiac output and stroke volume
• Patient sufficiently sedated (BIS between 40 and 60) and/or curarized (TOF \< 2/4 at the orbicularis) to avoid inspiratory effort
• Patient optimized on the hemodynamic level, in particular with regard to blood volume, following the data from hemodynamic monitoring and the recommendations of the French Society of Anesthesia and Resuscitation (RFE SFAR 2013 - Perioperative Vascular Filling Strategy)
• Patient covered by a Social Security plan
• Consent of close relatives or trusted person (if present)
• Patient admitted in polyvalent resuscitation within the Peri-Operative Medicine Unit of Clermont-Ferrand hospital suffering from respiratory distress syndrome for less than 24 hours

You may not qualify if:

• Contraindication to the use of cardiac output measurement by transpulmonary thermodilution
• Cardiac arrhythmia
• Severe valvulopathy
• Contraindication to the use of the Analysis of pulmonary aeration will be performed using the non-invasive technique of electrical impedance tomography with the placement of an electrode belt on the patient's chest. Values will be recorded with this belt :
• technique
• Left ventricular ejection fraction (LVEF) \< 45% and/or right ventricular failure
• History of pulmonary lobectomy and/or pneumectomy and/or known emphysema
• Patient with restrictive or obstructive lung disease
• Body mass index (BMI) \< 16.5 or \> 30 kg.m-2
• Pregnancy
• Major under legal protection (guardianship, curators, safeguard of justice)

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU

Clermont-Ferrand, 63000, France

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Central Study Contacts

Lise Laclautre

CONTACT

+33 473754963; llaclautre_perrier@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: May 9, 2022
• Study Start: March 1, 2022
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: May 12, 2022

Record last verified: 2022-02

Locations

FR (1)